With the goals of reducing health care costs and maximizing available health resources, there is an increasing trend towards providing surgical services through outpatient clinics, whenever possible. More than two thirds of patients receiving general anesthesia today are scheduled for same day discharge (Marshall, S. I. and F. Chung. 1999. Anesth. Analg. 88:508-517). Thus, there is significant emphasis placed on minimizing postoperative symptoms in order to facilitate early discharge. Basic criteria for discharge include stability of vital signs (including pain) within an acceptable range, ability to tolerate oral liquids, acceptable degree of nausea, and the ability to maintain an upright position without orthostasis (Marshall, S. I. and F. Chung. 1999. Anesth. Analg. 88:508-517). Further recovery is expected to take place at home after discharge. Recovery from anesthesia and surgery can be associated with residual sedation, pain, nausea, and vomiting (Marshall, S. I. and F. Chung. 1999. Anesth. Analg. 88:508-517; Myles, P. S. et al. 2000. Br. J. Anesth. 84:6-10).
Relatively few studies have evaluated recovery after discharge. Further, the available studies have deficiencies (i.e., partial reporting, non-uniformity of data collection techniques) that affect the utility of the study for drawing conclusions about recovery and postoperative symptoms following surgery with general anesthesia. The overall incidence of post-discharge symptoms in outpatients is reported to be approximately 45% for pain, 42% for drowsiness, 21% for fatigue, 18% for dizziness, 17% for nausea, and 8% for vomiting (Wu, C. L. et al. 2002. Anesthesiology 96:994-1003). Approximately 14% of patients undergoing general anesthesia experience these symptoms for 3 or more days (Myles, P. S. et al. 2000. Br. J. Anesth. 84:6-10), with 62% of patients requiring an average of 3.2 postoperative days to resume activities of daily living because of persistence of symptoms (Wu, C. L. et al. 2002. Anesthesiology 96:994-1003). Such statistics, however, do not describe the severity of symptoms.
Modafinil (PROVIGIL®, Cephalon Inc.) is a wakefulness-promoting agent approved by the FDA for patients with excessive daytime sleepiness associated with narcolepsy. The precise mechanism(s) through which modafinil promotes wakefulness is unknown. Modafinil is chemically un-related to typical central nervous system stimulants (i.e., amphetamines, methylphenidate), and has a pharmacological profile different than that of sympathomimetic amines. During clinical trials, modafinil (200 mg/d and 400 mg/d) was shown to significantly improve daytime wakefulness without affecting nighttime sleep (reviewed in 2002 Physician's Desk Reference, pages 1193-1196). In addition, modafinil has been shown to reduce fatigue and confusion in sleep-deprived pilots (Caldwell, J. A. et al. 2000. Psychopharmacology 150:272-282). Some of modafinil's pharmacological effects appear to be the type of effects that would counter the symptoms experienced by patients recovering from general anesthesia (i.e., feeling tired, sleepy and dizzy).
It has now been found that modafinil administration to patients decreases the severity of postoperative symptoms commonly associated with general anesthesia thus improving recovery from general anesthesia.